CN113476736B

CN113476736B - Adapter for needleless interface devices and method of connecting the same

Info

Publication number: CN113476736B
Application number: CN202110755224.3A
Authority: CN
Inventors: S·阿兰克; R·伍尔斯; L·马里唐; T·德武阿苏
Original assignee: Becton Dickinson France SA
Current assignee: Becton Dickinson France SA
Priority date: 2013-07-23
Filing date: 2014-07-23
Publication date: 2023-04-14
Anticipated expiration: 2034-07-23
Also published as: EP3024520A1; KR102414453B1; US12109386B2; EP3024520B1; KR20160034904A; KR102334969B1; CN113476736A; US20160158518A1; US10933228B2; EP3919103A1; ES2894033T3; US20210146112A1; ES2728315T3; EP3505208A1; JP6707025B2; EP2829297A1; JP2016525003A; CN104338236B; JP6932152B2; KR20210151243A

Abstract

The present invention relates to an adapter (1) with straight external threads for connecting a drug delivery device (100) and a needle-free interface device (200), comprising engagement means for mounting said adapter to a drug delivery device, and internal threads cooperating with said external threads (201) over a measured length L, said internal threads showing a major diameter D1 on a distal portion (5 b) of said length L for cooperating with the major diameter of said straight external threads, characterized in that said internal threads showing a major diameter D2 on a proximal portion (5 a) of said length L, wherein D2 is strictly smaller than D1, said internal threads further comprising a conical portion (5 c) connecting said proximal portion (5 a) and distal portion (5 b). The invention also relates to a drug delivery device comprising the adapter, and a method for connecting a needle-free interface device to the adapter, and to a drug delivery device.

Description

Adapter for needleless interface device and method of connecting said device thereto

The present patent application is a divisional application of the invention patent application having an application date of 2014 23/7, application number 201410436677.X entitled "adapter for needleless interface device and method of connecting the device thereon".

Technical Field

The present invention relates to an improved adapter for connecting a drug delivery device to a needle-free interface device. The invention also relates to a drug delivery device having the improved adapter. The invention also relates to a method of connecting said adapter to a needle-free interface device and a method of connecting a drug delivery device to a needle-free interface device via the adapter.

Background

Various medical devices are known for delivering and/or storing medical fluids, such as syringes, needle assemblies, infusion sets, and connectors, such as IV (intravenous), IM (intramuscular), subcutaneous connectors. For safety reasons, these medical devices can be correctly and securely combined together.

In this point of view and in order to simplify the medical procedure, a standard connection system has been developed which comprises a conical device assembly having specific dimensions complying with the standard specified by the ISO594 standard.

Basically, a drug delivery device, such as a hypodermic syringe, usually comprises a hollow body forming a reservoir for containing a medical product. In addition, the distal end of the body forming the cartridge typically includes a distal tip in which an axial passage is disposed and through which the product is expressed from the cartridge into the needle. For safety reasons, the needle may be arranged on a needle holder which is connected to the distal tip only when in use.

In this application, the distal end of a component or device may be understood as the end furthest from the user's hand, while the proximal end may be understood as the end closest to the user's hand. Likewise, in the present application, the "distal direction" may be understood as the direction of injection, with respect to which the drug delivery device the adaptor of the present invention is to be mounted, and the "proximal direction" may be understood as the opposite direction to said direction of injection.

According to ISO594, the distal tip of the medication delivery device is conical and exhibits a taper of 6%, thus constituting a male part which may be called a luer connection system. The recess of the luer connection system is, for example, a tapered 6% bore of the needle hub corresponding to the distal tip to be connected. Such luer connection systems allow a leak-free connection between the drug delivery device and, for example, a needle hub, and provide protection against contamination of the medical liquid product they contain.

Simple luer connection systems include male and female devices that simply conform to luer taper dimensions and are pressed together and held by friction. In any case, in order to improve the security and stability of the connection between the male and female means, a locking means is provided, called luer lock. In this case, an external projection is provided on the female means, which is screwed into a thread provided around the ring of the male means.

When the medicament delivery device is manufactured from plastic, the ring surrounding the raised means (i.e. the distal tip) may be integrally moulded with the medicament delivery device. However, drug delivery devices made of glass typically have a separate ring securely mounted at their distal tip.

Such a separate ring, or adaptor as it were, may be used for glass delivery devices or plastic delivery devices and is usually first mounted to the distal tip of the drug delivery device. A medical instrument, such as a needle hub, to be connected to the drug delivery device may then be screwed into the adapter in a second step.

However, in order to improve the safety of medical workers and prevent needle stick injuries, the use of "engineering controls" such as needleless interface devices is recommended. Needleless interface devices reduce the risk of needle sticks, reduce the risk of accidental exposure to blood borne pathogens, and are also believed to be key factors in preventing Blood Stream Infections (BSIs).

These needleless interface devices are to be connected to the drug delivery device by the above mentioned adapters. Needleless interface devices are particularly useful in the case of, for example, parenteral administration to a patient, where injection is carried out by means of an infusion device. In this case, the needleless interface device is an IV (intravenous) tube that connects the drug delivery device containing the product to be delivered to the patient's vein. Of course, the IV tubing and the drug delivery device must be assembled together correctly and securely.

In any event, some needleless interface devices were not originally developed based on connecting drug delivery devices, and they did not conform to the standard dimensions set forth for luer taper fittings, thereby creating poor conical fit at the tip that could result in misconnections. In addition, some needleless interface devices have internal safety systems that necessarily weaken their connection to the drug delivery device. Of course, such interior security systems often include spring-biased tabs that need to be replaced in order to allow product access. The presence of such a spring provides a high counter force for the needle-free interface device, which needs to be overcome when the needle-free interface device is connected to the drug delivery device and when the needle-free interface device is connected to the drug delivery device by means of the adaptor.

As a result, the previously screwed-down needle-free interface device may spontaneously unscrew from the adapter and, as a result, cause an accidental disconnection from the drug delivery device. In particular, the potential counter-force of the needle-free interface device combined with the non-standardized dimensions of the needle-free interface device results in a unscrewing force that is greater than the resistance of the connection and which may cause the needle-free interface device to prematurely disconnect from the adapter and thus from the drug delivery device. This phenomenon may be increased when the drug delivery device and its distal tip are made of glass, since the glass surface is necessarily a surface that slides easily.

Disclosure of Invention

Accordingly, there is a need for an improved adapter that ensures a secure fit of the needleless port device to the adapter, and that does not require the application of high torque when the needleless port device is screwed into the adapter. Of course, increasing the torque for screwing the needle-free interface device into the adapter fitted to the distal tip of the drug delivery device increases the risk of the adapter rotating around the distal tip of the drug delivery device. Such rotation is undesirable because it weakens the securement of the adapter on the distal tip and it does not allow the user to determine whether the needleless interface device is properly threaded into the adapter.

There is also a need for a drug delivery device having such an improved adapter.

One aspect of the present invention is an adapter that is intended to mount one of its ends, particularly its proximal end, to a drug delivery device, such as its distal tip, and its other end, i.e. its distal end, to a needle-free interface device having external threads to allow a secure connection between the needle-free interface device and the adapter, and between the needle-free interface device and the drug delivery device. In particular, the adapter of the present invention includes a special internal thread that ensures optimal fixation of the adapter to the needleless interface device such that the needleless interface device does not spontaneously and accidentally disconnect from the adapter during use.

A first aspect of the invention is an adapter for connecting a drug delivery device with a needle-free interface device having a straight external thread, the adapter comprising a unitary tubular body having a proximal end region with engagement means for mounting the adapter to the drug delivery device and a distal end region having an internal thread on its inner wall for mating with the external thread over a measured length L of the internal thread for engaging the needle-free interface device and the adapter. Said internal thread having a major diameter D1 of constant value cooperating with the major diameter of said straight external thread on a distal portion of said length L, said distal portion having a length L1, characterized in that a proximal portion of said internal thread over said length L has a major diameter D2, D2 being strictly smaller than D1, wherein said internal thread further comprises a conical portion connecting said proximal portion and said distal portion, said conical portion having a length L2.

In the present application, a "needle-free interface device" represents any device that is needle-free and is to be connected to an adapter, or is used to allow the delivery of a product from a drug delivery device to another medical device, such as a drip bag, a vial, an IV (intravenous) tube, an IM (intramuscular) tube, a catheter, or otherwise in order to safely close a filled drug delivery device prior to use and prevent any contamination, such as a cap located at a storage location of the drug delivery device.

In this application, "straight external threads" represent ridges that form a spiral around a cylinder. In particular, the height of the ridges and the diameter of the cylinder are both constant values. In the present application, "straight internal thread" means a ridge formed in a spiral shape on the inner wall of the pipe body. In particular, the height of the ridges and the inner diameter of the tubular body are constant values.

Another aspect of the invention is a drug delivery device comprising a distal tip defining an axial channel for delivery of a product contained in said drug delivery device, and at least one adapter as described herein mounted to said distal tip.

Another aspect of the invention is a method of connecting a needleless interface device having a straight external thread to an adapter as described herein, comprising at least the step of screwing said straight external thread into an internal thread of the adapter over said measured length L of said internal thread.

Another aspect of the invention is a method of connecting a drug delivery device to a needleless port device having a straight external thread, comprising the steps of:

-providing an adaptor as described herein,

-engaging the adapter to the drug delivery device by means of engagement means,

-screwing the straight external thread into the internal thread of the adapter over the measured length L of the internal thread.

The adapter of the present invention may be used, for example, to connect an IV tube to a drug delivery device.

The adapter of the present invention allows for a secure connection of a needle-free interface device having a straight external thread to the adapter and finally to a drug delivery device on which the adapter is mounted.

Surprisingly, the reduction in diameter of the proximal portion of the internal thread over its length, relative to prior art adapters, allows for better radial interference between the adapter and the needle-free interface device without the need to apply more torque to screw the needle-free interface device into the adapter. The resulting higher friction between the needleless interface device of the present invention and the adapter allows for tightening of the threads and stabilization of the final connection. The increased friction force can compensate for high counter forces that potentially exist in the needleless interface device.

In addition, to obtain such an improved stable connection, only limited torque, particularly lower torque than prior art adapters with conventional straight internal threads, is necessary to screw the needleless port device into the adapter by the adapter of the present invention. The engagement means of the adapter for mounting the adapter to the distal tip of the medication delivery device thus need not provide a high torque resistance.

The risk of accidental disconnection of the needleless interface device when screwed into the adaptor of the present invention is therefore greatly limited. The adapter of the present invention thus allows for repeatable and safe connection of a needle-free interface device to the adapter and, by extension, to a drug delivery device.

In addition, the reduction in diameter of the proximal portion of the internal thread over its length, measured in the direction of the longitudinal axis a of the barrel, provides the proximal portion of the barrel with a thicker wall, thus increasing the resistance of the barrel when the needleless interface device is screwed therein.

The distal portion of the internal threads of the adapter of the present invention has a length L1 and a major diameter D1 that mates with the straight external threads of the needleless interface device to be connected. The major diameter D1 thus has a constant value over the length L1 of the distal portion of the internal thread, and it defines a straight internal thread over the length L1. The distal portion of the internal thread of the adapter of the present invention thus defines a straight internal thread. The distal part of the straight internal thread is connected to the proximal part with a major diameter D2 strictly smaller than D1 by means of the conical part of the internal thread. The internal thread of the adapter of the present invention thus comprises a distal portion in the form of a straight internal thread; a proximal portion having a major diameter smaller than a major diameter of the distal portion; and a conical portion connecting the distal portion to the proximal portion. The value of the major diameter of the conical portion of the internal thread changes from D1 to D2.

In an embodiment, the proximal portion has a length L4, and D2 has a constant value over the length L4. The proximal part of the internal thread is thus a straight internal thread over the length L4.

The adapter of the present invention provides for smooth and gradual threading of the needleless interface device into the adapter of the present invention over the entire length L of the internal threads.

In embodiments, the ratio of D2 to D1 is in the range of 0.95 to 0.98. The additional friction provided to the external and internal threads thus allows for a more secure fixation between the needleless interface device and the adapter of the present invention.

In an embodiment the ratio of the length L1 of the distal section to the length L2 of the conical section is in the range of 0.9 to 1.1, preferably about 1. This embodiment provides the best stable connection between the needleless interface device and the adaptor of the present invention.

In an embodiment, the ratio of the length L1 of the distal portion to the length L4 of the proximal portion is in the range of 1.125 to 1.325, and preferably about 1.225. In an embodiment, the ratio of the length L2 of the conical portion to the length L4 of the proximal portion is in the range of 1.125 to 1.325, preferably about 1.225. This embodiment provides the best stable connection between the needleless interface device and the adaptor of the present invention.

In an embodiment, the engagement means comprises a proximal inner edge frictionally engaged at the distal tip of the drug delivery device. For example, the distal tip is conical and defines a channel for delivery of a product contained in the drug delivery device. In an embodiment, the inner edge is radially expandable.

In this application, the "user" represents a healthcare worker who needs to use the adapter of the present invention in order to connect a needleless interface device, such as an IV tube, thereto, or alternatively it may be a drug delivery device manufacturer who carries out the mounting of the adapter of the present invention to the distal tip of a drug delivery device in order to provide a drug delivery device to which the adapter has been mounted.

Of course, for example, the adapter of the present invention is typically first mounted to the distal tip of the drug delivery device by means of engaging means of the distal tip, such as by friction. The needleless port device is then screwed into the special internal thread of the adapter of the present invention. Due to this particular internal thread, the connection of the needle-free interface device to the adapter is optimal and the needle-free interface device will not be accidentally disconnected from the adapter.

In an embodiment, the distal tip of the drug delivery device is made of glass. In an embodiment, the distal tip is conical and the distal end is tapered.

Drawings

The invention and the advantages resulting therefrom will appear in the detailed description given below with reference to the accompanying drawings, in which:

figure 1 is a cross-sectional view of an embodiment of the adapter of the invention,

figure 2 is a partial enlarged view of the adapter according to figure 1,

figure 3 is a cross-sectional view illustrating the step of connecting the needleless interface device to the adaptor of figure 1,

fig. 4 is an exploded perspective view of a needle-free interface device connected to a drug delivery device by the adaptor of fig. 1.

Detailed Description

Referring to fig. 1, there is illustrated an adapter 1 of the present invention for connecting a drug delivery device, such as the drug delivery device 100 of fig. 4, to a needle-free interface device, such as the needle-free interface device 200 of fig. 3 and 4.

The adapter 1 comprises a tubular body 2 having a proximal end region 2a and a distal end region 2 b. As will appear below, the adapter 1 is to be connected to the medication delivery device 100 by its proximal end region 2 a.

In this view, the proximal end region 2a of the tubular body 2 has an inner annular rim 3 defining a central aperture 4. The inner annular rim 3 may be radially expandable in order to fit friction on the distal tip 101 of the drug delivery device 100. In the example shown, the inner annular edge 3 forms a plurality of circumferentially arranged projections 3a (also visible in fig. 4) which are separated from each other by a plurality of spaces 3b in order to provide said inner edge 3 with the ability to expand radially. As shown in fig. 4, the distal tip 101 is conical. The annular rim 3 forms an engagement means for engaging the adapter 1 to the distal tip 101 of the drug delivery device 100, since the inner surface of the protrusion 3a is to be in contact with the outer surface of the distal tip 101 when the adapter 1 is engaged onto the distal tip 101, so that the protrusion 3a may act as a retaining means for the adapter 1 to be connected to the distal tip 101. In other not shown embodiments the inner edge may be of an alternative design as long as the design provides flexibility to the edge.

The adapter 1 may be made of any plastic material that provides the desired flexibility, such as a material selected from Acrylonitrile Butadiene Styrene (ABS), polycarbonate (PC), polyoxymethylene (POM), polystyrene (PS), polyethylene terephthalate (PBT), polypropylene (PP), polyethylene (PE), polyamide (PA), thermoplastic elastomer (TPE), and combinations thereof.

The adapter 1 is to be connected to the needle-free interface device 200 through its distal region 2 b.

The distal end region 2b of the tube body 2 has an internal thread 5 extending on its inner wall along a length L measured along the longitudinal axis a of said tube body 2. The internal thread 5 defines peaks 6 and valleys 7 on the inner wall. The major diameter of the internal thread is conventionally defined by the diameter of the valley.

In the illustrated embodiment, as can be better seen in fig. 1 and 2, the internal thread 5 comprises a proximal portion 5a having a length L4, a distal portion 5b having a length L1 and a conical portion 5c connecting the proximal portion 5a to the distal portion 5b, the conical portion 5c having a length L2. L1, L2 and L4 are measured along the longitudinal axis a, and the overall length L of the internal thread 5 corresponds to the sum of L1, L2 and L4. The lengths L, L1, L2 and L4 are not equal to 0. For example, L1 may be in the range of 1.9mm to 2.1mm, L2 may be in the range of 1.9mm to 2.1mm, and L4 may be in the range of 2.35mm to 2.55 mm.

The distal portion 5b of the internal thread 5 defines a major diameter D1, while the proximal portion 5a of the internal thread defines a major diameter D2. As shown in fig. 1 and 2, D2 is strictly smaller than D1. As shown in fig. 1 and 2, the major diameter value of the conical portion 5c of the internal thread 5 is changed from D1 to D2. D2 has a constant value over the length L4. The proximal portion 5a of the internal thread 5 is thus a straight internal thread over the length L4.

Referring to fig. 3, D1 is the major diameter of the internal threads 5 that is to mate with the major diameter D3 of the straight external threads 201 on the needleless interface device 200. In fact, D1 is equal to D3, so that the straight male thread 201 and the distal end portion 5b of the female thread 5 of the adapter 1 are threadedly engaged by a uniform screw-down fit. D1 has a value that is constant over the length L1. Thus, the distal end portion 5b of the internal thread 5 is a straight internal thread over the length L1. In this application, "straight external thread" means a ridge that forms a helix around a cylinder. In particular, the height of the ridges and the diameter of the cylinder are constant. In the present application, "straight internal thread" means a ridge forming a spiral line on the inner wall of the pipe body. In particular, the height of the ridges and the inner diameter of the tubular body are constant.

In the embodiment of fig. 3, the straight external threads 201 define peaks 202 and valleys 203. The major diameter D3 of the external thread 201 is the diameter defined by the peaks 202 and is constant throughout the length L3 of the external thread 201. The length L3 of the external thread 201 corresponds overall to the length L of the internal thread 5 of the adapter 1.

The needleless interface device 200 portion of fig. 3 and 4 is illustrated. The straight external threads 201 form the proximal end of the needleless interface device 200. The needle-free interface device 200 may be any device to be connected to the adapter 1 or used to allow transfer of a product from a drug delivery device to another needle-free medical device, such as a pouched drip, vial, IV (intravenous) tube, IM (intramuscular) tube, catheter, or otherwise to securely close a filled drug delivery device prior to use and prevent any contamination, such as a cap located at a storage location of the drug delivery device.

Since D2 is smaller than D1, the proximal portion 5a of the internal thread 5 does not have a suitable size for conventional threaded engagement with the straight external thread 201, the result of which will be apparent later in the description. In particular, the ratio of D2 to D1 is in the range of 0.95 to 0.98.

Preferably, the ratio of the length L1 of the distal portion 5b of the internal thread 5 to the length L2 of the conical portion 5c measured along the longitudinal axis of said tubular body 2 is in the range 0.9 to 1.1, preferably about 1. In an embodiment, the ratio of the length L1 of the distal portion 5b to the length L4 of the proximal portion 5a is in the range of 1.125 to 1.325, preferably about 1.225. In an embodiment, the ratio of the length L2 of the conical portion 5c to the length L4 of the proximal portion 5a is in the range of 1.125 to 1.325, preferably about 1.225.

As shown in fig. 4, the adapter 1 of fig. 1-3 is intended to connect the drug delivery device 100 to a needle-free interface device 200. The connection of the needle-free interface device 200 to the drug delivery device 100 will be described with reference to fig. 1-4.

The drug delivery device 100 is aligned with the adaptor 1 and has a common longitudinal axis a. The distal tip 101 of the medication delivery device is conical, tapering distally and defining an axial channel 102 for the transport of the product (not shown) contained therein. The axial passage 102 is open at its distal end. In embodiments not shown, the outer surface of the distal tip 101 may have an annular protrusion, or alternatively an annular ridge.

The distal tip 101 may be made of a plastic or glass material. In an embodiment, the distal tip 101 is made of a glass material. In another embodiment, the distal tip 101, like the drug delivery device 100, is made of a plastic material selected from the group consisting of Crystal Clear Polymers (CCP), acrylonitrile Butadiene Styrene (ABS), polycarbonate (PC), polystyrene (PS), polypropylene (PP), polyethylene (PE), polyamide (PA), and combinations thereof.

In a first step, the adapter 1 is engaged by its radially expandable inner edge 3 to the distal tip 101 of the medicament delivery device 100. This step appears to be easy to perform due to the distal tapering shape of the distal tip 101 and the radial expansion capability of the inner edge 3. In an embodiment not shown, the engagement of the adapter and its correct positioning is possible due to its proper fit with the annular groove on the distal tip of the medication delivery device. In another embodiment, not shown, the adapter may be held at the proximal part of the distal tip of the medication delivery device by an annular ridge.

Referring to fig. 4, the adapter 1 is fixed on the distal tip 101 of the drug delivery device 100 by a friction fit of the inner rim 3 on the distal tip 101. In particular, the protrusions 3a of the inner edge 3 exert a radially inward force on the outer surface of the distal tip 101 and limit the rotation and movement of the adapter 1 relative to the distal tip 101.

The user grasps the needleless interface device 200 and screws the straight external thread 201 into the internal thread 5 of the adapter 1. He first screws the straight external thread 201 into the distal portion 5b of the internal thread 5 by means of a uniform and conventional screwing, since D1 and D3 cooperate and the distal portion 5b of the internal thread 5 defines a straight internal thread. Then, since the conical portion 5c and the proximal portion 5a of the internal thread 5 have different diameters, in particular values smaller than D1, the major diameter of the internal thread 5 over the length L2 of the conical portion 5c and the length of the proximal portion 5a no longer perfectly fits the major diameter D3 of the straight external thread 201. This difference results in an increase in the friction between the straight male thread 201 and the conical portion 5c and the proximal end portion 5a of the female thread 5, without preventing the straight male thread 201 from being completely screwed into the adapter 1. Of course, this tightening is still possible up to the proximal end of the internal thread 5 of the adapter 1, and the user does not need to significantly increase the applied torque to obtain a greater friction between the external thread 201 and the internal thread 5. As a result, the risk of rotation of the adapter 1 relative to the distal tip 101 when the needleless interface device 200 is screwed into the adapter 1 is greatly limited.

The user then continues to thread the needle-free interface device 200 into the adapter 1 over the entire length L of the internal threads 5 until the proximal end of the needle-free interface device 200 reaches the proximal end of the proximal portion of the internal threads 5.

Surprisingly, the reduction of the major diameter of the internal thread 5 at its proximal portion, and for example at its conical portion, allows for a greater friction force to be generated by the straight external thread of the needle-free interface device entering the adapter of the present invention and a more stable connection to be made without the need to apply a greater torque to screw the needle-free interface device into the adapter and without the need to prevent the external thread 201 of the needle-free interface device from being screwed into the proximal end of the internal thread 5 of the adapter 1.

In particular, when the ratio of D2 to D1 is in the range of 0.95 to 0.98, the tightening is gentle and gradual. Preferably, the ratio of the length L1 of the distal section to the length L2 of the conical section is in the range of 0.9 to 1.1, preferably about 1. The resulting connection is particularly stable and strong.

The risk of spontaneous disconnection of the needle-free interface device 200 screwed into the adapter 1 of the present invention is thus greatly limited, even when the distal tip is made of glass or when the needle-free interface device comprises a spring-biased tab for providing a high counter force against the connection. Thus, the adapter of the present invention allows for a repeatable and safe connection of the needle-free interface device on said adapter, which allows for a secure and reliable liquid passage from the drug delivery device and the needle-free interface device. In addition, the adapter of the present invention is compatible with many connectors available on the market.

In addition, the reduction in the major diameter of the internal thread 5 at the proximal portion of the internal thread 5 provides a thicker wall for the proximal portion of the barrel 2, thereby increasing the resistance of the barrel 2 as the needleless interface device 200 is screwed in. Thus, the adapter is more stable.

The adapter of the present invention allows for a more secure connection of a needle-free interface device on the distal tip of a drug delivery device. The risk of the needle-free interface device being unscrewed spontaneously and accidentally from the adapter of the present invention is greatly limited.

Claims

1. A needle-free interface device (200) arranged with straight external threads (201), said needle-free interface device (200) comprising an adapter (1) for connecting a drug delivery device (100) to said needle-free interface device (200), said adapter comprising a unitary tubular body having a proximal region (2 a) arranged with engagement means for mounting said adapter to said drug delivery device and a distal region (2 b) having on its inner wall internal threads (5) cooperating with said straight external threads (201) over a determined length L thereof, said internal threads having on a distal portion (5 b) of said length L a major diameter D1 cooperating with said straight external threads with a constant value, said distal portion (5 b) having a length L1, characterized in that said internal threads have a major diameter D2 over a proximal portion (5 a) of said length L, wherein the major diameter D2 is strictly smaller than the major diameter D1, wherein said internal threads further comprise a conical portion (5 c) connecting said distal portion (5 a) to said distal portion (5 b) of said length L, said distal portion (5 b) having a conical length D2.

2. The needle-free interface device (200) of claim 1, wherein the ratio of the major diameter D2 to the major diameter D1 is in the range of 0.95 to 0.98.

3. The needle-free interface device (200) of claim 1, wherein the proximal portion (5 a) has a length L4, and the major diameter D2 is a constant value throughout the length L4.

4. The needle-free interface device (200) according to any one of claims 1-3, wherein the ratio of the length L1 of the distal portion (5 b) to the length L2 of the conical portion (5 c) is in the range of 0.9 to 1.1.

5. The needle-free interface device (200) of claim 4, wherein the ratio of the length L1 of the distal portion (5 b) to the length L2 of the conical portion (5 c) is about 1.

6. The needle-free interface device (200) according to any one of claims 1-3, wherein the engagement means comprises a proximal inner edge frictionally engageable to a distal tip (101) of a drug delivery device.

7. The needle-free interface device (200) of claim 6, wherein the proximal inner edge is radially expandable.

8. The needle-free interface device (200) of claim 3, wherein the ratio of the length L1 of the distal portion (5 b) to the length L4 of the proximal portion (5 a) is in the range of 1.125 to 1.325.

9. The needle-free interface device (200) of claim 8, wherein the ratio of the length L1 of the distal portion (5 b) to the length L4 of the proximal portion (5 a) is about 1.225.

10. The needle-free interface device (200) of claim 3, wherein a ratio of the length L2 of the conical portion to the length L4 of the proximal portion is in a range of 1.125 to 1.325.

11. The needle-free interface device (200) of claim 10, wherein a ratio of the length L2 of the conical portion to the length L4 of the proximal portion is about 1.225.

12. The needle-free interface device (200) according to any one of claims 1-3, wherein the needle-free interface device (200) further comprises the drug delivery device (100) comprising a distal tip (101) defining an axial channel (102) for delivery of a product contained within the drug delivery device, the adapter (1) being mounted on the distal tip.

13. The needle-free interface device (200) of claim 12, wherein the distal tip (101) is made of glass.

14. The needle-free interface device (200) of claim 12, wherein the distal tip (101) is conical and distally tapered.

15. The needle-free interface device (200) of claim 13, wherein the distal tip (101) is conical and distally tapered.